This page about new gout drugs was last reviewed, or updated on 5 September 2014.
There is now a good deal of gout research going on into gout drugs at a practical level. That is, to produce drugs that work better than existing ones. Here's a round up.
Ulodesine (BCX4208) is a purines inhibitor of purines conversion to uric acid. It works earlier in the process than allopurinol or febuxostat. It has been trialed up to the end of phase 2, i..e. one more phase to complete before it could apply for approval.
Its owners, Biocryst Pharamceuticals, are looking for a pharma partner to undertake the phase 3 trials.
LESINURAD (RDEA594) - AN APPROVAL APPLICATION IS COMING
In August 2014 AstraZeneca PLC announced the results of three phase 3 trials for its uric acid excretor drug, now called Lesinurad and originally named RDEA594. The trials were called Clear1, Clear2, (over 600 trialists) and Crystal 324 trialists). With a duration of over a year, these were the last main trials before an application for medical authority approval.
In earlier trials, Lesinurad has achieved a mean (average) serum (blood) uric acid (UA) change from a baseline (i.e. starting level) of greater than 7.0 mg/dL of about 45% in ten days to two weeks. i.e. an average of UA 7.23 mg/dL down to 3.96 mg/dL. In at least one other trial it has got uric acid down to even lower levels than this.
Rapid falls in uric acid levels often bring on gout attacks. So far the developing company has not reported this effect.
Lesinurad, which encourages uric acid excretion by inhibiting the URAT1 transporter in the kidneys, was tested, in these latest placebo controlled trials, for use with either allopurinol or febuxostat. They both inhibit uric acid production. The idea is to target blood (serum) uric acid from, as it were, two directions.
The developers said Lesinurad met its primary endpoint (target) for uric acid levels of 6.0 mg/dL and 5.0 mg/dL, when tested with allopurinol (6.0) and febuxostat (5.0). The febuxostat trial was conducted among tophaceous (tophi) gout patients, who usually have suffered gout for longer and have developed tophi nodules on their bodies.
Safety issues But its developers reported that they are still studying safety and tolerability issues in ongoing trials. These have been reported to be upper respiratory tract infections, nasopharyngitis (nasal passage inflammation – nose and pharynx), arthralgia (joint pain) and back pain.
AstraZenca said it will proceed with medical authority approvals (probably the U.S. and E.U. nations initially) for Lesinurad at 200 mg once daily taken with either allopurinol or febuxosat.
RDEA3170.....Following on behind Lesinurad (RDEA594) is another potential new gout drug from the same company currently called RDEA3170. It's described as a next generation URAT1 inhibitor. It works in a similar way to Lesinurad in the kidneys, but almost certainly it's potentially a better inhibitor and therefore could prove more effective at lowering serum (blood) uric acid.
CANAKINUMAB (trade name: ILARIS)
This is another of the new gout drugs for gout pain relief. It has been trialed at a dose of up to 150 mg against triamcinalone acetonide at 40 mg in 191 gout patients who could not take colchicine or NSAIDs, or for whom NSAIDs don't work. On average, at 150 mg it achieved 50% gout pain relief in one day, a day faster than triamcinolone achieved a similar degree of relief for gout pain.
And the probability of subsequent gout flares with Canakinumab was just 3.7%, in its latest trial. This was very interesting news, which no doubt the developers will look into in more detail, because this medication is primarily for pain relief, not gout attacks' prevention. Arcalyst (rilonacept) has shown a similar capability.
This drug will also, if approved, compete in the pain relief market against colchicine and corticosteroids like prednisone. It will go into phase 3 trials.
If it's better than colchicine and corticosteroids (with their infamous side effects) gout sufferers who need to reduce the pain of attacks with these, will welcome it. Like Arcalyst (rilonacept) and xoma 052, canakinumab (Ilaris) is a biologic agent i.e. injections/infusions. It targets the Interleukin-1 inflammation excretion event, described in the copy above about Arcalyst.
In September 2011, the U.S. FDA decided not to approve Ilaris. The risk/reward profile needed to be better. Its developers have also applied for approval in European Union countries, Canada and Switzerland. If these jurisdictions approve it they will be the first to do so.
For treating gout pain without drugs please visit our dealing with gout pain page.
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